The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1

April 13, 2021 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Single-blinded, Parallel Design Phase I Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. After Subcutaneous Injection in Postmenopausal Female

A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

To investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. 3.75 mg after subcutaneous injection in postmenopausal female

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Yonsei-ro, Seodaemun-gu 50-1
      • Seoul, Yonsei-ro, Seodaemun-gu 50-1, Korea, Republic of, 03722
        • Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy menopausal female
  • β-hCG is negative at screening and before administration of investigational drug
  • Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc.
  • Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and < 28.0

Exclusion Criteria:

  • History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease
  • Uncontrolled diabetes mellitus in the last three months
  • Pregnancy or breast feeding
  • History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
  • Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CKD-841 A-1(=leuprorelin acetate 3.75mg)
Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
Drug: CKD-841 A-1 3.75mg
Single injection, subcutaneous injection
Other Names:
  • CKD-841
Experimental: CKD-841 A-1(=leuprorelin acetate 1.88mg)
Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
Drug: CKD-841 A-1 1.88mg
Single injection, subcutaneous injection
Other Names:
  • CKD-841
Experimental: CKD-841 D(=leuprorelin acetate 2.92mg)
Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
Drug: CKD-841 D 2.92mg
Single injection, subcutaneous injection
Other Names:
  • CKD-841
Active Comparator: Leuplin Inj.(=leuprorelin acetate 3.75mg)
Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.
Drug: Leuplin Inj. 3.75 mg
Single injection, subcutaneous injection
Other Names:
  • Leuplin.Inj

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PK(Cmax)
Time Frame: From before injection to up to 1008 hours post injection
Cmax(Maximum concentration of drug in plasma) of Leuprorelin
From before injection to up to 1008 hours post injection
PK(AUClast)
Time Frame: From before injection to up to 1008 hours post injection
AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin
From before injection to up to 1008 hours post injection
PK(AUCinf)
Time Frame: From before injection to up to 1008 hours post injection
AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin
From before injection to up to 1008 hours post injection
PK(AUC7-t)
Time Frame: From before injection to up to 1008 hours post injection
AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin
From before injection to up to 1008 hours post injection
PK(CL/F)
Time Frame: From before injection to up to 1008 hours post injection
CL/F(Apparent Clearance) of Leuprorelin
From before injection to up to 1008 hours post injection
PK(Vd/F)
Time Frame: From before injection to up to 1008 hours post injection
Vd/F(Apparent Volume of Distribution) of Leuprorelin
From before injection to up to 1008 hours post injection
PK(Tmax)
Time Frame: From before injection to up to 1008 hours post injection
Tmax(Time to Cmax/Time to Emax) of Leuprorelin
From before injection to up to 1008 hours post injection
PK(t1/2)
Time Frame: From before injection to up to 1008 hours post injection
t1/2(Terminal elimination half-life) of Leuprorelin
From before injection to up to 1008 hours post injection
PD(AUEC0-42d below baseline)
Time Frame: From before injection to up to 1008 hours post injection
AUEC0-42d below baseline((AUEC that is below the baseline from 0 h to 42 days)) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
From before injection to up to 1008 hours post injection
PD(AUEC0-28d below baseline)
Time Frame: From before injection to up to 1008 hours post injection
AUEC0-28d below baseline(AUEC that is below the baseline from 0 h to 28 days) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
From before injection to up to 1008 hours post injection
PD(Area under the response (% change from baseline) curve)
Time Frame: From before injection to up to 1008 hours post injection
AUEC(Area under the response (% change from baseline) curve) above baseline of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
From before injection to up to 1008 hours post injection
PD(Tmax)
Time Frame: From before injection to up to 1008 hours post injection
Tmax(Time to Cmax/Time to Emax) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
From before injection to up to 1008 hours post injection
PD(Tmin)
Time Frame: From before injection to up to 1008 hours post injection
Tmin(Time to Emin) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
From before injection to up to 1008 hours post injection
PD(Emax)
Time Frame: From before injection to up to 1008 hours post injection
Emax(Maximum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
From before injection to up to 1008 hours post injection
PD(Emin)
Time Frame: From before injection to up to 1008 hours post injection
Emin(Minimum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
From before injection to up to 1008 hours post injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Assessment by evaluating adverse events(AEs).
Time Frame: From day1 to day 56
Assessment of the safety of subjects by evaluating adverse events(AEs).
From day1 to day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Collaborators

Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

April 8, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A55_03PK2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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